Apotex Recalls Aripiprazole Tablets Due to Dissolution Failures
Apotex Corp. is recalling Aripiprazole Tablets 15 mg because they failed to meet dissolution specifications. The affected products were distributed nationwide in the USA.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Apotex Corp. is voluntarily recalling Aripiprazole Tablets, USP 15 mg, packaged in 1000-count and 30-count bottles. The recall is due to the tablets failing to meet required dissolution specifications, which means they may not break down and release the medication as intended.
The affected products are identified by NDC 60505-2675-8 (Lot PZ6716, Exp. 02/2021) and NDC 60505-2675-3 (Lot PZ6715, Exp. 02/2021). A total of 552 bottles of the 1000-count version and 3,192 bottles of the 30-count version were distributed nationwide in the USA.
Consumers and healthcare providers should stop using the recalled tablets and contact their healthcare provider or pharmacist for a replacement or further instructions. The FDA classifies this as a Class II recall, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
- Manufacturer
- Apotex Corp.
- Category
- Drug — Antipsychotic
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- a) PZ6716 Exp. 02/2021
- b) PZ6715 Exp. 02/2021
Distribution
Distributed nationwide across the United States.
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